Reduced-pressure system and method employing a gasket

ABSTRACT

A reduced-pressure treatment system for treating a tissue site on a patient includes a gasket releasably attached around a perimeter of the tissue site that may remain in place for an extended time and allows an over-drape to be attached to it. The system and method further may include a manifold sized and configured to be placed in contact with the tissue site; the over-drape positioned over the manifold and sealed to the gasket to create a sealed space between the over-drape and the tissue site; and a reduced-pressure source fluidly coupled to the sealed space to deliver reduced pressure to the tissue site. A method is also presented.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/025,271, filed Sep. 12, 2013, which is a divisional of U.S. patentapplication Ser. No. 13/487,763, filed Jun. 4, 2012, which is adivisional of U.S. patent application Ser. No. 12/195,115, filed Aug.20, 2008, which claims the benefit under 35 USC §119(e) of the filing ofU.S. Provisional Application No. 60/965,755, entitled “Reduced PressureSystem Employing a Gasket Disposed Circumferentially Around a TissueSite”, filed Aug. 21, 2007. Each of the above applications areincorporated herein by reference for all purposes.

BACKGROUND

1. Field of the Invention

The present invention relates generally to medical treatment systems andin particular to a reduced-pressure system and method employing agasket.

2. Description of Related Art

Clinical studies and practice have shown that providing a reducedpressure in proximity to a tissue site augments and accelerates thegrowth of new tissue at the tissue site. The applications of thisphenomenon are numerous, but application of reduced pressure has beenparticularly successful in treating wounds. This treatment (frequentlyreferred to in the medical community as “negative pressure woundtherapy,” “reduced pressure therapy,” or “vacuum therapy”) provides anumber of benefits, including faster healing and increased formulationof granulation tissue. Typically, reduced pressure is applied to tissuethrough a porous pad or other manifolding device. The porous padcontains cells or pores that are capable of distributing reducedpressure to the tissue and channeling fluids that are drawn from thetissue.

In order to use reduced pressure on a tissue site, a pneumatic seal isachieved over the dressing using a semi-permeable drape that is sealedto the patient's epidermis. In order to achieve this seal, an adhesivehas been used at times or a sealing tape. At times, to help provide abetter seal, healthcare providers have navigated the difficult task ofusing sealing material to form strips around the wound before placingthe drape over the dressing and wound. With reduced-pressure therapy, adressing is applied and usually is periodically changed. This typicallymeans that the dressing is changed with some frequency—often three timesa week or more. When such changes take place, the sealing tape isremoved. This can cause irritation to the periwound region and pain tothe patient.

It would be desirable to have a system and method that would allow forwound dressing changes with less pain for the patient and withoutrequiring removal of all components of the system. It would also bedesirable to provide a system that would be relatively easy to apply toa patient. Moreover, it would be desirable to have a system with a goodpneumatic seal formed over the wound site.

SUMMARY

Problems with existing reduced-pressure systems and methods areaddressed by the systems and methods of the illustrative embodimentsdescribed herein. According to one illustrative embodiment, areduced-pressure treatment system for treating a tissue site on apatient includes a gasket releasably attached around a perimeter of thetissue site; a manifold sized and configured to be placed in contactwith the tissue site; an over-drape positioned over the manifold andsealed to the gasket to create a sealed space between the over-drape andthe tissue site; and a reduced-pressure source fluidly coupled to thesealed space to deliver reduced pressure to the tissue site. The gasketmay be operable to remain in place for an extended time.

According to another illustrative embodiment, a method for treating atissue site on a patient with reduced pressure includes the steps of:releasably attaching a gasket around a perimeter of the tissue site;placing a manifold in contact with the tissue site; disposing anover-drape over the manifold; sealing the over-drape to the gasket tocreate a sealed space between the over-drape and the tissue site; andproviding reduced pressure to the sealed space to treat the tissue site.

The illustrative embodiment of the systems and methods of the presentinvention may provide for a number of perceived advantages. A fewexamples follow. Technical advantages of the present invention mayinclude that system is relatively easy to apply. Another advantage isthe system may be easier on the periwound region of the epidermis.Another advantage is that the patient may experience relatively reducedor eliminated pain associated with dressing changes. Another advantageis that the likelihood of pneumatic leak is decreased. These are onlysome examples.

Other objects, features, and advantages of the illustrative embodimentswill become apparent with reference to the drawings and detaileddescription that follow

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic, perspective view with a portion in cross-sectionof an illustrative embodiment of a reduced-pressure system employing agasket;

FIG. 2 is a schematic, plan view of an illustrative embodiment of agasket disposed circumferentially around a tissue site;

FIG. 3 is a schematic, perspective view of an illustrative embodiment ofa dispenser for applying an illustrative gasket to a periwound area of apatient's epidermis; and

FIG. 4 is a schematic, cross-sectional view of a portion of anillustrative embodiment of a reduced-pressure system employing a gasket.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

In the following detailed description of the illustrative embodiments,reference is made to the accompanying drawings that form a part hereof.These embodiments are described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is understood thatother embodiments may be utilized and that logical structural,mechanical, electrical, and chemical changes may be made withoutdeparting from the spirit or scope of the invention. To avoid detail notnecessary to enable those skilled in the art to practice the embodimentsdescribed herein, the description may omit certain information known tothose skilled in the art. The following detailed description is,therefore, not to be taken in a limiting sense, and the scope of theillustrative embodiments are defined only by the appended claims.

Referring to FIG. 1, an illustrative embodiment of a reduced-pressuretreatment system 100 for treating a wound 102 at a tissue site 104,which is centered in a wound bed. System 100 may include a manifoldmember 108, or simply manifold; an over-drape 110; and areduced-pressure subsystem 112. System 100 includes gasket 128.

In one illustrative embodiment, the manifold member 108 is made from aporous and permeable foam-like material and, more particularly, areticulated, open-cell polyurethane or polyether foam that allows goodpermeability of wound fluids while under a reduced pressure. One suchfoam material that has been used is the VAC® Granufoam® Dressingavailable from Kinetic Concepts, Inc. (KCI) of San Antonio, Tex. Anymaterial or combination of materials might be used for the manifoldmaterial provided that the manifold material is operable to distributethe reduced pressure. The term “manifold” as used herein generallyrefers to a substance or structure that is provided to assist inapplying reduced pressure to, delivering fluids to, or removing fluidsfrom a tissue site. A manifold typically includes a plurality of flowchannels or pathways that are interconnected to improve distribution offluids provided to and removed from the area of tissue around themanifold. Examples of manifolds may include without limitation devicesthat have structural elements arranged to form flow channels, cellularfoam, such as open-cell foam, porous tissue collections, and liquids,gels, and foams that include or cure to include flow channels. Themanifold material might also be a combination or layering of materials;for example, a first manifold layer of hydrophilic foam might bedisposed adjacent to a second manifold layer of hydrophobic foam to formthe manifold member 108.

The reticulated pores of the Granufoam® material, that are in the rangeof about 400 to 600 microns, are helpful in carrying out the manifoldfunction, but again other materials may be used. A material with ahigher, or lower, density (smaller pore size) than Granufoam® materialmay be desirable in some situations. The manifold member 108 may also bea reticulated foam that is later felted to thickness of about ⅓ itsoriginal thickness. Among the many possible materials, the followingmight be used: Granufoam® material or a Foamex technical foam(www.foamex.com). In some instances it may be desirable to add ionicsilver to the foam in a microbonding process or to add other substancesto the manifold member such as antimicrobial agents. The manifold member108 could be a bio-absorbable material or an anisotropic material.

The over-drape 118 covers the manifold member 108 and extends past aperipheral edge 114 of the manifold member 108 to form a drape extension116. Drape extension 116 has a first side 118 and a second,patient-facing side 120. Drape extension 116 may be sealed against agasket 128 by sealing apparatus 124, such as an adhesive 126. Sealingapparatus 124 may take numerous forms, such as an adhesive sealing tape,or drape tape or strip; double-side drape tape; adhesive 126; paste;hydrocolloid; hydrogel; or other sealing means. If a tape is used, itmay be formed of the same material as the over-drape 110 with apre-applied, pressure-sensitive adhesive. Pressure-sensitive adhesive126 may be applied on a second, patient-facing side 120 of drapeextension 116. Adhesive 126 provides a substantially pneumatic sealbetween the over-drape 110 and the gasket 128. Before the over-drape 110is secured to the patient, removable strips covering the adhesive 126may be removed.

Over-drape 110 may be an elastomeric material that has pore sizes lessthan about 20 microns, but other materials and sizes might be used.“Elastomeric” means having the properties of an elastomer and generallyrefers to a polymeric material that has rubber-like properties. Morespecifically, most elastomers have elongation rates greater than 100%and a significant amount of resilience. The resilience of a materialrefers to the material's ability to recover from an elastic deformation.Examples of elastomers may include, but are not limited to, naturalrubbers, polyisoprene, styrene butadiene rubber, chloroprene rubber,polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber,ethylene propylene diene monomer, chlorosulfonated polyethylene,polysulfide rubber, polyurethane, EVA film, co-polyester, and silicones.Further still, over-drape materials may include a silicone, 3M Tegaderm®drape material, acrylic drape material, such as one available fromAvery, or an incise drape material.

Gasket 128 has a gasket material 130 with a first side 132 and a second,patient-facing side 134. A second attachment apparatus 136 may becoupled to the second side 134 of the gasket material 130 for releasablyattaching the gasket 128 to the patient's epidermis 106, or moregenerally skin. The gasket material 130 may be a thin polymer film, suchas polyurethane, polyester, silicone, or a hydrocolloid, or couldinclude any suitable gasket material. The second attachment apparatus136 holding the gasket 128 in place may be a relatively water-resistantmaterial, such as an Avery® brand Wet-stick adhesive, a colloid,acrylic, polyisobutylene (PIB), etc. The second attachment apparatus 136allows the gasket 128 to be held in place for an extended time, e.g. oneto two weeks or more, and then to be removed. The over-drape 110 may bere-attachable to the gasket 128 should the clinician find a need to viewthe wound and re-attach the over-drape 110. This allows the gasket 128to stay in place for an extended time without significant agitation ofthe periwound area of the epidermis 106.

Reduced-pressure subsystem 112 includes a reduced-pressure source 140,which can take many different forms. Reduced-pressure source 140provides a reduced pressure as a part of system 100. The term “reducedpressure” as used herein generally refers to a pressure less than theambient pressure at a tissue site 104 that is being subjected totreatment. In most cases, this reduced pressure will be less than theatmospheric pressure at which the patient is located. Alternatively, thereduced pressure may be less than a hydrostatic pressure of tissue atthe tissue site 104. It is often desirable for the reduced-pressuresource 140 to develop a continuous reduced pressure below atmosphericpressure and also be able to deliver a dynamic pressure, i.e., to varythe reduced pressure in a cycle or operate in a continuous orintermittent mode. The operable range of reduced pressure may varywidely as needed, but would typically include 200 mm Hg belowatmospheric. When one refers to increasing the reduced pressure, ittypically refers to increasing the absolute value of the negative gaugepressure, and likewise, when one speaks of decreasing the reducedpressure, it typically means that the absolute value of the negativegauge pressure is decreasing.

In the illustrative embodiment of FIG. 1, reduced-pressure source 140 isshown having a reservoir region 142, or canister region. An interposedmembrane filter, such as hydrophobic or oleophobic filter, might beinterspersed between a delivery conduit, or tubing, 144 and thereduced-pressure source 140. A medial portion 146 of conduit 144 mayhave one or more devices, such as device 148. For example, the device148 might be another fluid reservoir, or collection member to holdexudates and other fluids removed. Other examples of devices 148 thatmight be included on the medial portion 146 of delivery conduit 144include pres sure-feedback devices, volume detection systems, blooddetection systems, infection detection system, flow monitoring systems,temperature monitoring systems, etc. Some of these devices may be formedintegral to the reduce-pressure source 140. For example, areduced-pressure port 141 on reduced-pressure source 140 may include afilter member that includes one or more filters, e.g., an odor filter.

The reduced pressure developed by reduce-pressure source 140 isdelivered through the delivery conduit 144 to a reduced-pressureinterface 150, which might be an elbow port 152. In one illustrativeembodiment, port 152 is a TRAC® technology port available from KineticConcepts, Inc. of San Antonio, Tex. Interface 150 allows the reducedpressure to be delivered through over-drape 110 and realized withinsealed space 154. In this illustrative embodiment, elbow port 152extends through over-drape 110 and into manifold member 108.

Referring now to FIG. 2, an illustrative embodiment of a gasket 200 isshown disposed circumferentially about wound 202. A small margin 204 isshown at the wound edge 206. It will be appreciated from FIG. 2 thatirregular shaped wounds, such as wound 202, should be accommodated. Oneway to accommodate the irregular shape is to attach gasket 200 using agasket tape, i.e., a gasket material with attachment means that can beapplied to the patient like a tape. In this regard, FIG. 3, shows anillustrative embodiment of a gasket tape dispenser 300.

Gasket tape dispenser 300 dispenses gasket 302, or gasket tape, whichhas a gasket material 304 and an attachment apparatus 306. The dispenser300 may take many forms, but in this embodiment, contains a firstchamber portion 308, which holds a roll of gasket tape 302. Thehealthcare provider can thus use the dispenser 300 to dispense gasket302 about the perimeter of the tissue site proximate wound 310 on orthrough epidermis 311. To do so, the dispenser 300 is moved in thedirection shown by arrow 314. In some instances, it may be desirable toinclude a releasable backing material on the attachment means 306 untilit is ready for application; in such a situation, a second chamber 312(shown in broken lines) may be included for collecting the removedbacking material. The second chamber 312 may include a spring-loadedspindle that pulls the removed backing material on to it. There arenumerous other ways the gasket 302 might be dispensed.

Referring again to FIG. 2, in operation, the healthcare providertreating a wound 202 may, after appropriately cleaning and preparing theperiwound region, apply a gasket 200 about the wound 202 using adispenser, such as dispenser 300 in FIG. 3, or otherwise placing thegasket 200 proximate the wound 202. The gasket 200 provides along-lasting perimeter about the wound 202 that facilitates attachmentof an over-drape and that allows the over-drape to be removed withoutrequiring the gasket 200 to be removed. By “long-lasting,” it is meantthat the gasket 200 could remain attached and operable for as long asone to two weeks or even longer.

Referring again to FIG. 1 and continuing consideration of oneillustrative embodiment in operation, once the gasket 128 has beenapplied in a manner analogous to that just described for gasket 200 andthe manifold 108 put in place, the over-drape 110 may be placed over thewound 102 and attachment apparatus 124 used to secure the over-drape 110to the gasket 128 and in particular to releasably attach drape extension116 to the gasket 128. In this instance, attachment apparatus 124 is anadhesive layer 126 and requires removal of a removable backing beforeapplication. Once over-drape 110 is sealed, it provides thepneumatically sealed space 154. The reduced-pressure interface 150 isapplied through over-drape 110 to allow reduced pressure fromreduced-pressure subsystem 112 to reach the manifold 108. Thereduced-pressure subsystem 112 may be activated and reduced pressuresupplied to manifold 108 in sealed spaced 154.

Referring now to FIG. 4, another illustrative embodiment for releasablysealing over-drape 402 to first side 404 of gasket 406 is shown. Gasket406 has a sealing apparatus 408 on a second, patient-facing side 410that holds and seals the gasket 406 in a long-lasting way to thepatient's epidermis 412. In this illustrative embodiment, the over-drape402 is secured using a bead 414 of adhesive applied to the first side404 of the gasket 406 and against a second, patient-facing side 416 ofover-drape 402. The bead 414 may be applied using an applicator similarto a caulk gun. In still another illustrative embodiment, a materialcapable of drying and adhering to a patient's epidermis periwound mightbe painted on or sprayed on and allowed to dry.

It should be apparent from the foregoing that an invention havingsignificant advantages has been provided. While the invention is shownin only a few of its forms, it is not just limited but is susceptible tovarious changes and modifications without departing from the spiritthereof.

What is claimed is:
 1. A system adapted for assembly to treat a tissue site, comprising: a manifold adapted for placement proximate to the tissue site; a gasket adapted for placement on a periwound area around the tissue site; an over-drape adapted to cover the manifold and to extend past a peripheral edge of the manifold to form a drape extension; a first attachment apparatus comprising a first adhesive adapted for application between the drape extension and the gasket; and a second attachment apparatus comprising a second adhesive adapted for application between the gasket and the periwound area; wherein the first attachment apparatus is weaker than the second attachment apparatus; wherein the first adhesive is different from the second adhesive.
 2. The system of claim 1, wherein the gasket comprises a thin polymer film having a first side and a second, patient-facing side, and wherein the first attachment apparatus is adapted to be positioned on the first side of the gasket and the second attachment apparatus is adapted to be positioned on the second, patient-facing side of the gasket.
 3. The system of claim 2, wherein the thin polymer film comprises polyurethane.
 4. The system of claim 2, wherein the thin polymer film comprises polyester.
 5. The system of claim 1, wherein the first attachment apparatus is separated from the second attachment apparatus by the gasket.
 6. The system of claim 1, wherein the second attachment apparatus comprises an adhesive tape.
 7. The system of claim 1, wherein the first attachment apparatus comprises a pressure-sensitive adhesive.
 8. The system of claim 1, wherein the first attachment apparatus comprises a bead of adhesive.
 9. The system of claim 1, wherein the gasket comprises a hydrocolloid. 